Application Sponsors
| ANDA 205186 | AJANTA PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 20MG BASE | 0 | ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE |
| 002 | TABLET;ORAL | EQ 40MG BASE | 0 | ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2018-07-20 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-11-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 7 | Null | 31 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AJANTA PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 205186
[companyName] => AJANTA PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ELETRIPTAN HYDROBROMIDE","activeIngredients":"ELETRIPTAN HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ELETRIPTAN HYDROBROMIDE","activeIngredients":"ELETRIPTAN HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/20\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-07-20
)
)